FDA 510(k)

Ventoux VC2; Ventoux VC3

K-번호: K223120 · 2024-12-02

결정일2024-12-02

제품 코드CBK

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

Ventoux VC2; Ventoux VC3 is the device name listed in this FDA 510(k) record. The listed applicant is Flight Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2024-12-02 under 510(k) number K223120. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Ventoux VC2; Ventoux VC3?

Ventoux VC2; Ventoux VC3 is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is Flight Medical Innovations , Ltd.. The 510(k) number is K223120.

When did Ventoux VC2; Ventoux VC3 receive FDA 510(k) clearance?

Ventoux VC2; Ventoux VC3 received FDA 510(k) clearance on 2024-12-02, under 510(k) number K223120.

Who is the listed applicant for Ventoux VC2; Ventoux VC3?

The FDA 510(k) record lists Flight Medical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ventoux VC2; Ventoux VC3?

The FDA product code for Ventoux VC2; Ventoux VC3 is CBK.

Flight Medical Innovations , Ltd.를 신청인으로 등재한 기타 기록

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